Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer|
- Time to progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Best overall response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Clinical benefit [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
- Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
- Determine the best overall response rate and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111904
|United States, Florida|
|Florida Cancer Specialists - Bonita Springs|
|Bonita Springs, Florida, United States, 34135|
|United States, Illinois|
|Midwest Cancer Research Group, Incorporated|
|Skokie, Illinois, United States, 60077|
|United States, Louisiana|
|Louisiana Oncology Associates - Lafayette|
|Lafayette, Louisiana, United States, 70506|
|United States, New York|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|United States, Texas|
|Southwest Regional Cancer Center - Central|
|Austin, Texas, United States, 78705|
|Study Chair:||John S. MacDonald, MD||Beth Israel Comprehensive Cancer Center - West Side Campus|